An observational study in Epilepsy and Cryptogenic Epilepsy, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
S100B protein is a biomarker produced mainly by astrocytes and released into the bloodstream in the event of brain injury, with levels rising rapidly and markedly in acute conditions such as traumatic brain injury, stroke, or epileptic seizures, before declining quickly. Increased S100B levels following a convulsive seizure have been reported, suggesting potential value in distinguishing epilepsy from other causes; however, its use in the etiological assessment of transient loss of consciousness has not yet been studied. Loss of consciousness represents a common reason for Emergency Department visits and involves a wide range of causes, making diagnosis challenging due to often limited clinical history and resulting in numerous investigations. A biomarker such as S100B could help guide diagnosis more rapidly, particularly in distinguishing epilepsy from other causes, thereby reducing the need for additional tests and shortening hospital stay. To date, no study has evaluated the performance of S100B measurement in the etiological workup of transient loss of consciousness. The hypothesis underlying this study is that measurement of S100B levels in the Emergency Department could help differentiate epileptic seizures from other etiologies, particularly cardiac causes, and thus reduce additional investigations and hospital stay. This prospective observational study primarily aims to assess the diagnostic performance of S100B measurement for identifying epilepsy compared with other causes of transient loss of consciousness in adult patients presenting to the Emergency Department for this reason. The study will begin on April 30 and will last 15 months. In practice, eligible patients who do not oppose participation will undergo an additional blood sample at the time of initial sampling required for clinical management, with this sample used to measure plasma S100B levels; patient management will otherwise remain identical to standard care. Three months after the Emergency Department visit, an adjudication committee composed of a neurologist, a cardiologist, and an emergency physician will determine the final diagnosis based on all available data, including any additional investigations performed after the initial visit. The primary endpoint is the area under the ROC curve (AUROC) of S100B measurement, evaluating its ability to discriminate epilepsy from other causes of transient loss of consciousness.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 100 is close to the median of 102 across 521 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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The study population will consist of adult patients presenting to the Emergency Department of Henri Mondor University Hospital during the inclusion period for an episode of transient loss of consciousness. Eligible patients will be screened consecutively and included if they meet all predefined inclusion criteria and none of the exclusion criteria.
Adult ≥ 18 years old
Exclusion Criteria:
Symptoms occurring more than 12 hours ago
Area under the ROC curve (AUROC) of S100B measurement, assessing its ability to discriminate epilepsy from other causes of transient loss of consciousness
The primary outcome measure is the area under the ROC curve (AUROC) of S100B measurement, assessing its ability to discriminate epilepsy from other causes of transient loss of consciousness. The reference standard is the final diagnosis established by an adjudication committee at 3 months, blinded to the S100B result. The AUROC will be estimated with its 95% confidence interval (95% CI). Statistical significance will be assessed using a test comparing the AUROC to 0.5. The test will be considered of diagnostic interest if the AUROC is ≥ 0.75 and/or if the lower bound of the 95% CI is \> 0.65, and if the p-value of the test versus 0.50 is \< 0.05.
Time frame: 15 Months
Determination of the optimal S100B threshold for the diagnosis of epilepsy using Youden's index
Time frame: 15 months
Assessment of the diagnostic performance associated with the optimal S100B threshold for epilepsy diagnosis (sensitivity, specificity, positive predictive value, and negative predictive value).
Time frame: 15 months
Subgroup analyses based on adjudicated etiological diagnoses
Diagnostic performance of S100B will be evaluated separately within each etiological subgroup defined by the adjudication committee (epilepsy, cardiac syncope, hypoglycemia, vasovagal syncope)
Time frame: 15 Months
Analysis of S100B levels according to patient comorbidities
Plasma S100B concentrations will be measured using standard immunoassay techniques.
Time frame: 15 months
Analysis of results based on the time between symptom onset and sample collection (in hours).
Time frame: 15 months
Analysis of results according to patient age (<65 years, 65-79 years, and ≥80 years).
Time frame: 15 months
Analysis of results based on the occurrence of head trauma during the episode and, if applicable, the time between the trauma and the measurement of S100B (in hours).
Time frame: 15 months
Plan to share: No — DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris